1Dept. of Diagnostic and Interventional Radiology, University Medical Center Freiburg, Faculty of Medicine, University of Freiburg Division of Medical Physics Freiburg, Deutschland; 2Stockert GmbH Freiburg, Deutschland; 3Universitäts-Herzzentrum Freiburg - Bad Krozingen Institut für Experimentelle Kardiovaskuläre Medizin Freiburg im Breisgau, Deutschland; 4Universitäts-Herzzentrum Freiburg - Bad Krozingen Klinik für Kardiologie und Angiologie Freiburg im Breisgau, Deutschland; 5Imricor Medical Systems Inc. Burnsville, USA
Methods: Six PFA lesions were created in the atria and the left ventricle of a female landrace pig (weight: 70kg, age: 3 months) using a focal catheter (Boston Scientific Intellanav Stablepoint) and a prototype RF generator (Stockert SmartRE PFA Generator C1.2). A monopolar protocol with biphasic asymmetric pulses up to 2kV was applied, and electroanatomical mapping was performed pre/post ablation (Boston Scientific Rhythmia HDx). Animals were euthanized 2h after ablation and 15min after intravenous injection of 0.5mmol/kg Gd contrast agent. In addition, 250ml of 1% triphenyltetrazolium chloride (TTC) was injected 10min prior to euthanasia. Both atria and part of the LV were fixated with formaldehyde and NaCl. Ex vivo MRI was performed 4 days post fixation at 3T (Siemens PrismaFit). T1- and R2*-weighted images were acquired at Δx=0.47mm isotropic resolution. Additionally, the devices were tested in the 3T MRI system was done using an MR-compatible monofocal catheter (Imricor Vision-MR) and an organic phantom.
Results: All lesions were visualized in both gross pathology and ex vivo MRI. In the T1-weighted images lesions appear hyperintense (contrast-to-noise ratio lesion/healthy tissue = 9.1±5.0). The mean lesion width/depth on ex vivo MRI were (9.2±3.8)/(5.2±1.4)mm compared to (8.3±3.4)/(4.6±2.0)mm on gross pathology, and a high linear correlation was found between MRI and pathology (R=0.98, p<0.001). The hemorrhagic parts of the lesions showed an increased R2* with a mean of (90.5±9.9)s-1 compared to (23.2±1.0)s-1 in healthy tissue, and their widths/depths were (5.7±1.9)/(3.8±2.0)mm on MRI and (5.5±1.8)mm (3.5±2.0)mm on gross pathology (R=0.99, p<0.001). The MR-compatible PFA system was successfully used to create electroporation in the organic phantom, validated by TCC staining.
Conclusion: This study demonstrates the feasibility of assessing PFA-induced lesions with MRI in an ex vivo porcine model. Lesion dimensions from MRI and gross pathology strongly correlate, and R2* values reliably identify the hemorrhagic lesion components. In combination with the MR-compatible PFA system, this method will be used for longitudinal studies on the formation of chronic lesions, providing valuable insights into PFA-based treatments of cardiac arrhythmia.